Diseased mitral valves frequently need repair to function properly. The mitral valve leaflets or supporting chordae may degenerate and weaken or the annulus may dilate leading to valve leak (valve insufficiency). Mitral valve repair is frequently performed with aid of an annuloplasty ring or helix, used to reduce the diameter of the annulus, or modify the geometry of the annulus in any other way. In some procedures the annuloplasty ring is fixated around the annulus of the valve.
U.S. Pat. No. 8,603,161 discloses a device for attaching a prosthesis, having a slide that is pushed against a substantially horizontal anvil to cause legs of a clip to rotate outwards. The anvil can be slid out of the way so that the clip is released from the device.
EP0826340 discloses a clip device comprising a body having a substantially tubular shape. Two flaps are positioned at the end of the body receiving the clip. The flaps may pivot at the flexible portion. The other end of each flap is positioned between the legs of the clip, and keeps the legs spaced apart. When the pusher is advanced and pushing the clip out of the body the flaps are moved from the position between the legs of the clip, so that the clip may assume the heat-set predefined shape.
A problem with the prior art is the complexity of the devices which requires a several operating steps in which the several movable parts must be engaged in sequence. The procedure thus becomes more complicated and time consuming. Complex devices that are expensive to manufacture also lead to loosing the advantage of using disposable single use devices. A further problem with prior art is lack of stability between the clip position relative the catheter. It is important to be able to attach the clip at the desired site with high accuracy, which can be compromised if the clip can not be held in a controlled position before engaging the tissue. Frequently the target site may be of complex anatomy and there may be movement, such as the motion of the beating heart in addition to the operator's movements, that lead to difficulties in positioning a clip when having such lack of stability.
Further, devices and clips in the prior art are not suitable for annuloplasty implants such as helix rings that are to be positioned on either side of a heart valve. Such device would not provide sufficient fixation of such implant and lead to traumatic effects since the fixation structure must ensure the correct position of the device over time.
The above problems may have dire consequences for the patient and the health care system. Patient risk is increased.
Hence, an improved stapling device for attaching annuloplasty implants such as helix rings would be advantageous and in particular allowing for ensuring long-term functioning, less complex procedure, and less traumatic effects on the anatomy and increased patient safety. A kit with a stapling device and a clip for providing such improvements, and a related method would also be advantageous.